DIA 2017 Annual Meeting

EU pediatric investigation plans (PIPs) have become a routine part of the global drug development process. Small and medium-sized US companies that develop new and efficacious drugs are less prepared for the enthusiastic pediatric requirements from the European Medicines Agency. As a consequence, once they approach EU registration, they give in more to EMA's PIP requirements than would be necessary. Even large companies are unable to avoid commitment to questionable studies in children. This has become a serious obstacle in the development of efficacious new drugs, and industry needs better arguments to push back requirements that are expensive and do not improve child health. In 2017 there will be a new report on the EU pediatric legislation to the EU parliament. While the EMA and EU Commission will report on its successes (more PIPs, more clinical trials in children), there are concerns being voiced about having even stronger pediatric obligations from the pharmaceutical industry. This session will focus on the need for better PIP analysis, analysis of lessons learned, and reflections on how to modify the EUPL, while offering a chance for a substantial improvement in industry’s relationship with clinicians and parents. It will also examine how we can prepare the groundwork for countering new proposals to impose stronger pediatric obligations in the EU and US.